16 results · 22ms · Sources: EU EUDAMED, US FDA

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HARDYDISK NETILMICIN, 30MCG

FDA 510(k)
FDA Class 2 ·Microbiology

SYR 10 ML FIL SALINE SHORTLENGTH PLUNGER ROD

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·August 19, 2019

FRONT-LOAD POLYPROPYLENE SYRINGE

FDA 510(k)
FDA Class 2 ·Cardiovascular

KRONNER LOW PROFILE SCOPE HOLDER

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

SYR 10 ML FIL SALINE SHORTLENGTH PLUNGER ROD

FDA Adverse Event
Malfunction ·BECTON DICKINSON AND COMPANY·Product code NGT·August 21, 2019

Span-America

FDA UDI
SPAN-AMERICA MEDICAL SYSTEMS, INC.·H93300266300000·ZIMMER LAM ARM CRADLE 12/CS

INSET GUARD

FDA Adverse Event
Malfunction ·UNOMEDICAL A/S·Product code FPA·March 30, 2026

VERSAPOINT

FDA Adverse Event
Malfunction ·ETHICON, INC.·Product code HIH·March 13, 2013

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORP.·Product code LZG·February 9, 2011

SOFTCLIX PLUS LANCET DEVICE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·February 8, 2008

BD PRE-FILLED POSIFLUSH¿ NORMAL SALINE SYRINGE

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·September 26, 2019

SYR 10 ML FIL SALINE SHORTLENGTH PLUNGER ROD

FDA Adverse Event
Malfunction ·BECTON DICKINSON AND COMPANY·Product code NGT·October 17, 2019

Safety Sideport Knife 1.0mm 45¿, REF 378210 Product Usage: Indicated to make stab incisions during ophthalmic surgery

FDA Enforcement
Class II ·Terminated·Beaver Visitec·July 11, 2018

1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

FDA Enforcement
Class II ·Ongoing·B-K Medical A/S·November 12, 2025

CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018